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The Participant Agreement for Contact Tracing (PACT) Study: Enhancing Partner Notification Services.

NCT ID: NCT00207493

Last Updated: 2012-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

494 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2007-09-30

Brief Summary

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Patients diagnosed with chlamydial infections (a sexually transmitted disease) are asked to notify their sex partners and tell them to seek medical evaluation. This project tests an enhancement to the materials provided to patients to help convince their partners to seek evaluation against the standard of care, which is a brief notification instruction. The desired outcomes are greater levels of notification by participants of their partners and lower levels of reinfection among participants.

Detailed Description

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Patients diagnosed with chlamydial infections (a sexually transmitted disease) are asked to notify their sex partners and tell them to seek medical evaluation: patient referral. Rates of actual referral by patients are unknown, but estimates derived from several evaluations suggest somewhere between 30 - 55% of partners are notified and tested (for chlamydia). Current prevalence and yearly rates of infection suggest this level of partner notification and treatment is insufficient to control the disease.

As a program, this project has disseminated notification activities to community health centers that see chlamydial infections, all under the aegis of the awardee (Boston Medical Center). Diagnosis and partner notification can be recorded remotely , but centrally accessed through a secure database. To enhance patient referral effectiveness, this project tests brief instructions to refer (standard of care) against a "kit" containing a specific notification of exposure to chlamydia, an accurate health message about the nature and prognosis of the infection (treated and untreated), options for seeking free or low-cost evaluation and treatment, and a satisfaction survey. A second, crossed condition is pure patient referral against a contract (72 hours to notify, after which study staff will refer cases to public health professionals for notification).

Principal outcomes measured are levels of notification by participants of their partners and levels of reinfection among participants. We also measure psychosocial mediating effects, as well as potential unintended consequences of patient referral: incident partner violence against prevalent (baseline rates) violence, depressed affect

Conditions

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Chlamydia Infection Contact Tracing

Keywords

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sexually transmitted disease structural intervention behavioral intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Kit enhancement to referral

Intervention Type BEHAVIORAL

patient referral versus contract referral

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Sexually active AND
* 15 years old or older AND at least one of:
* Individuals with genitourinary symptoms requiring empiric treatment for chlamydia, OR
* People who self-report that they have had sex with someone who has been diagnosed with an STD within the past 30 days OR
* Asymptomatic female patients with cervicitis diagnosed via a routine pelvic examination.

Exclusion Criteria

* Subsequent lab confirmation of no chlamydial infection OR
* Sex partner of previously enrolled person OR
* Fear of violence from partner during notification.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Hogben, PhD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Guillermo Madico, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R30/CCR 119162

Identifier Type: -

Identifier Source: secondary_id

CDC-NCHSTP-3305

Identifier Type: -

Identifier Source: org_study_id